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ABT-126 in Subjects with Alzheimer's Disease on Acetylcholinesterase Inhibitors

  • Completed

This Phase II efficacy and safety study will evaluate the drug ABT-126 as a new treatment for people with mild to moderate Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 90 Years Both No
March 2012
October 2013
420

++Meets NINCDS/ADRDA criteria for probable Alzheimer's disease++Taking stable dose of an acetylcholinesterase inhibitor (donepezil or rivastigmine) for at least 90 days prior to screening++Mini-Mental Status Examination (MMSE) total score of 12 to 24; Cornell Scale for Depression in Dementia (CSDD) score of 10 or less; Modified Hachinski Ischemic Scale (MHIS) score of 4 or less++Good general health, based on results of medical history, physical examination, vital signs, laboratory profile, and electrocardiogram++Caregiver who will provide support, ensure compliance with study medication and procedures, and provide accurate information about the subject's status during the study

++Subject has taken galantamine or memantine within 60 days prior to screening++Clinically significant abnormal laboratory values at screening++History of any significant neurologic disease other than Alzheimer's disease, including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, seizures++Mental retardation++History of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities++Clinically significant uncontrolled medical or psychiatric illness.

This is a Phase II study designed to evaluate the efficacy and safety of ABT-126 in older adults with mild to moderate Alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. Participants will be randomized to receive one of two ABT-126 doses or a placebo for a 24-week treatment period. Participants in this study may be eligible to take part in a related extension study; see NCT01690195 in ClinicalTrials.gov for details.

For more information about this clinical trial or the study sites, call or email the study contacts Alison Torres (847-938-2226; alison.torres@abbott.com) or Betty Prine (847-937-6928; betty.prine@abbott.com).

Name City State Zip Status Primary Contact
Site Delray Beach Florida 33445

Site Bennington Vermont 05201

Site Orlando Florida 32806

Site Staten Island New York 10312

Site Elk Grove Village Illinois 60007

Site San Francisco California 94109-4841

Site Fresno California 93720

Site West Palm Beach Florida 33407

Site Hamden Connecticut 06518

Site Tampa Florida 33613

Site Long Beach California 90806

Site Gatineau None J9A 1K7

Site Montreal None H3T 1E2

Site Toronto None M3B 2S7

Site Verdun None H4H 1R3

Site Peterborough None K9H 2P4

AbbVie (prior sponsor, Abbott)

Name Role Affiliation
Laura Gault, MD Study Director Abbott

Name Phone Extension Email
Alison Torres 847-938-2226 alison.torres@abbott.com
Betty Prine 847-937-6928 betty.prine@abbott.com

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer`s Disease on Stable Doses of Acetylcholinesterase Inhibitors